BSX is a BUY - News From the FDA Stent Advisory Panel

Discussion in 'Stocks' started by ByLoSellHi, Dec 7, 2006.

  1. U.S. panel weighs risk of drug-coated heart stents

    Thu Dec 7, 2006 11:56 PM IST139

    By Lisa Richwine

    GAITHERSBURG, Md. (Reuters) - A U.S. advisory panel heard evidence on Thursday about risks of drug-coated stents, the tiny mesh tubes used to prop open arteries in millions of heart patients.

    A controversy erupted this year when research showed the devices may cause dangerous blood clots in some patients months after being implanted. Johnson & Johnson and Boston Scientific Corp. sell drug-coated stents in the United States.

    Hoping to guide doctors and patients, U.S. Food and Drug Administration officials turned to a panel of 21 outside experts for advice on whether the device's benefits outweigh the risks and if extended anti-clotting drug therapy should be recommended.

    They also sought input on whether safety concerns applied equally to stents made by both companies.

    Drug-coated stents were hailed as a major advance just three years ago because the drug coating cuts the chances of an artery closing again, a problem reported with about a quarter of bare-metal stents.

    Now, doctors are rethinking their quick adoption of drug-coated stents after blood clotting was seen in a small percentage of patients. Blood clots can kill or cause heart attacks.

    Data so far indicate a "small but significant" increase in blood clots a year or more after a drug-coated stent is placed, FDA reviewer Andrew Farb told the panel. However, "it has not been established" if that leads to an elevated risk of having a heart attack or dying, he said.

    Some panel members pressed Farb on why the clots had not been shown to increase those problems.

    "One explanation could be the numbers are too small to show a difference. We're talking about relatively rare events," he said.

    The FDA panel was scheduled to provide input on Thursday about the risks when drug-coated stents are placed according to instructions on their labels.

    But an estimated 60 percent or more of drug-coated stents are implanted in harder-to-treat patients who do not meet criteria for approved uses, FDA officials said. The panel will start discussing use in those patients late on Thursday and is set to give advice on that issue on Friday.

    Nearly 6 million patients worldwide have received drug-coated stents, and the market is worth nearly $6 billion a year, according to an estimate by JP Morgan analysts.

    Makers said the drug-coated versions offered advantages over bare-metal alternatives.

    Boston Scientific said it found a slight increase in blood clots with its Taxus drug-coated stent but no higher rate of heart attacks or deaths.

    "The things patients care about -- am I more likely to be dead or have a large heart attack -- the answer is 'no,'" said Boston Scientific Chief Medical and Scientific Officer Donald Baim.

    Johnson & Johnson said data so far show no significant difference between the risk of blood clots from its Cypher drug-coated stent and bare-metal versions.

    "Patients treated with the Cypher stent and bare-metal stents have a similar overall risk of stent (clotting) over four years," said Campbell Rogers, chief technology officer at Johnson & Johnson unit Cordis.

    Abbott Laboratories Inc. and Medtronic Inc. market their versions of drug-coated stents in other countries, and are aiming for U.S. launches as early as mid-2007.
  2. Shorting right here...thks.
  3. BSX was at $44 in August of 04.

    How much downside risk do honestly think hasn't been baked into this profitable company, that makes devices that are medical necessities, now that it's under $17?

    You think it will drop to $5?

    I'll take the other side of your trade gladly.
  4. Not only are they safe, but the FDA is going to make it more difficult for new drug coated stents to be approved, thus giving BSX and JNJ, the only two makes of such devices now, more time to reap duopoly profits.

    JNJ, Boston Scientific Heart Stents Are Safe, Says FDA

    Posted on Dec 8th, 2006 with stocks: ABT, BSX, JNJ, MDT

    An FDA advisory panel determined that Johnson & Johnson and Boston Scientific's drug-coated heart stents are safe for the approved patient population, despite recent concerns about increased risk of blood clots.

    Doctors have been questioning the accelerated adoption of these stents after a rise in blood clotting was seen in a limited number of patients.

    Three years ago, drug-eluting stents were deemed a major advance when it was determined that the drugs reduced the chances that the treated artery would re-close.

    There is a question as to whether safety concerns apply to both Johnson & Johnson and Boston Scientific products equally.

    Analysts estimate that this market is worth $6 billion a year and 6 million patients have been implanted with the product worldwide. Abbott Laboratories and Medtronic Inc. sell versions of drug-coated stents internationally and plan to enter the U.S. market in mid-2007.
  5. Simply a case of the good news being factored in. Another point, was i saw the line about increasing competition starting in 07', so I figured it was a good short, for a short term trade.
  6. BSX is up 3% in premarket trading after inking an exclusive use deal with the Cleveland Clinic.

    3% on a day when volume is almost guaranteed to be light.

    This is why I love proven medical companies, whether device or pharma, that have proven products.